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Functional outcome in two different designs of knee replacements

A randomised controlled trial to compare the functional outcome between the PFC Sigma fixed bearing posterior cruciate ligament (PCL) preserving implant with the PFC Sigma posterior stabilised mobile bearing implant

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN05635855
Enrollment
90
Registered
2008-07-24
Start date
2007-09-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total knee replacement surgery Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]

Interventions

Two groups of patients will be compared. The only difference in treatment between the two groups will be the use of the PFC Sigma RPF which has a mobile bearing and requires sacrificing of the posteri

Sponsors

Queen Margaret University (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Ninety suitable men and women (no age limits) with osteoarthritis undergoing a Total Knee Replacement (TKR) at the New Royal Infirmary, Edinburgh who are able to actively flex the knee more than 90 degrees will be recruited from the waiting list of three orthopaedic surgeons. Suitable patients will be identified from medical records and will be living in the Lothian region. All subjects will be medically fit for testing and have no other lower limb impairments.

Exclusion criteria

Exclusion criteria: 1. Inflammatory polyarthritis 2. Disorders of the feet, ankles or hips or spine causing abnormal gait or significant pain 3. Dementia 4. Severe visual impairment 5. Neurological conditions affecting movement 6. Inability to give informed consent 7. Any other disorders of the contra-lateral knee causing abnormal gait or significant pain. Subjects with radiological evidence of osteoarthritis of the contra-lateral knee will be included provided the patient does not report significant pain or restriction in motion of the contra-lateral knee. Similarly patients with total knee arthroplasty of the contra-lateral knee will be included provided the patient does not report significant pain or restriction in motion of the contra-lateral knee.

Design outcomes

Primary

MeasureTime frame
Knee excursion during functional activities as measured using electrogoniometry. Primary and secondary outcome measures are collected around one to three weeks before surgery and one year after surgery for both groups.

Secondary

MeasureTime frame
1. The passive range of motion of the knee 2. Flexor and extensor strength as measured using a MIE myometer 3. Function as measured by the American Knee Society Score 4. Function, stiffness and pain as measured by the Western Ontario and McMaster Universities (WOMAC) questionnaire 5. Quality of life, using the 36-item short form health survey, version 2 (SF-36 v2) 6. Pain, using the Visual Analogue Score (0 = no pain to 10 = unbearable pain) 7. Walking speed 8. Physical mobility as measured by an activity monitor (activPAL) 9. Canadian Occupational Performance Measure Primary and secondary outcome measures are collected around one to three weeks before surgery and one year after surgery for both groups.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026